On June 22, 2009, the President signed
the Family Smoking Prevention and Tobacco Control Act (the Tobacco
Control Act) (Public Law 111-31) into law. The Tobacco Control Act
grants FDA important authority to regulate the manufacture,
marketing, and distribution of tobacco products to protect the
public health generally and to reduce tobacco use by minors. The
Tobacco Control Act provides for lower civil money penalties for
violations of sale and distribution, including youth access, and
advertising and promotions restrictions issued under the Federal
Food, Drug, and Cosmetic Act (FD&C Act), as amended by the
Tobacco Control Act, for retailers who have implemented a training
program that complies with standards developed by FDA for such
programs. FDA intends to promulgate regulations establishing
standards for approved retailer training programs. Until FDA
promulgates these regulations, the agency intends to use the lower
maximum civil money penalties schedule for all retailers who
violate the restriction of the sale and distribution of cigarettes
and smokeless tobacco products, whether or not they have
implemented a training program. However, FDA may consider further
reducing the civil money penalty for retailers who have implemented
a training program. In the interim, the guidance document
associated with this collection of information is intended to
assist tobacco retailers in implementing training programs for
employees.
This is a revision to the
approved information collection. Pursuant to the publishing of the
deeming rule, FDA has added vape shop retailers (3,300) who are
expected to participate in this program. The estimated total number
of respondents has increased by 3,300 to 273,900. After further
review of the recordkeeping burden, FDA believes the “review and
update” IC was already covered by the “training program” IC.
Therefore we have removed this IC which resulted in a decrease of
135,300. As a result of these changes the total estimated annual
burden has decreased by 92,080 hours (3,042,740 - 2,950,660) for a
new total of 2,950,660.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
Tobacco Retailer Training Program